First prospective Intergroup Translational Research Trial of the potential predictive value of p53 in patients with locally advanced/inflammatory or large operable breast cancer

First prospective Intergroup Translational Research Trial assessing the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane versus a non taxane regimen

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN58579496

Enrollment

1850

Registered

2010-05-19

Start date

2001-04-25

Completion date

Unknown

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

1. Non-taxane arm: either FEC100 (epirubicin 100 mg/m2 with 5-fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2) every 3 weeks for 6 cycles or Canadian FEC (oral cyclophosphamide on days 1-14 and

patients also receive filgrastim (G-CSF) subcutaneously on days 2-15 or until blood counts recover) x 6 (every 3 weeks for 6 cycles) 2. Taxane arm: 3 cycles Docetaxel (every 3 weeks for 3 cycles) foll

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed breast cancer: Locally advanced or inflammatory disease: 1.1. + T4a-d, any N, M0, or 1.2. + Any T, N2 or N3, M0 1.3. + Large T2 or T3 breast cancer requiring tumor shrinkage prior to breast conservation surgery 2. Frozen tumor sample available: 2.1. One incisional biopsy, or 2.2. Two trucut biopsies from a 14G needle 3. No prior chemotherapy 4. No prior radiotherapy 5. Age: 70 and under 6. Female 7. Performance status: World Health Organization (WHO) 0 - 1 8. Neutrophil count greater than 1,500/mm^3 9. Platelet count greater than 100,000/mm^3 10. Bilirubin less than 1.2 mg/dL 11. Serum glutamic oxaloacetic transaminase (SGOT) less than 60 IU/L 12. Creatinine less than 1.35 mg/dL 13. Left ventricular ejection fraction (LVEF) normal by echocardiography or multiple gated acquisition scan (MUGA)

Exclusion criteria

Exclusion criteria: 1. No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix 2. No serious uncontrolled medical condition 3. No uncontrolled psychiatric or addictive disorders 4. Not pregnant or nursing 5. Fertile patients must use effective contraception

Design outcomes

Primary

Measure	Time frame
Progression free survival, calculated from date of randomisation to the first evidence of progression or recurrence or death, whichever occurs first	—

Secondary

Measure	Time frame
1. Distant metastasis free survival, calculated from the date of randomisation to the first evidence of recurrent disease outside radiation field or death, whichever occurs first 2. Survival, calculated from date of randomisation to date of death 3. Clinical and pathological responses, assessed after 3rd cycle and at the end of neoadjuvant chemotherapy according to Response Evaulation Criteria in Solid Tumours (RECIST) criteria for tumour progression 4. Toxicity, measured according to Common Toxicity Criteria (CTC) scale version 2.0	—

Measure

Time frame

1. Distant metastasis free survival, calculated from the date of randomisation to the first evidence of recurrent disease outside radiation field or death, whichever occurs first 2. Survival, calculated from date of randomisation to date of death 3. Clinical and pathological responses, assessed after 3rd cycle and at the end of neoadjuvant chemotherapy according to Response Evaulation Criteria in Solid Tumours (RECIST) criteria for tumour progression 4. Toxicity, measured according to Common Toxicity Criteria (CTC) scale version 2.0

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026